BEUDAMED
    FDA Adverse Event Other Summary report: N

    MED-ED COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 3030359 · Received March 28, 2013

    Report

    Report Number
    9710014-2013-00113
    Event Type
    Other
    Date Received
    March 28, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 25, 2013
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN EXPLANTED. IF IT SHOULD BE EXPLANTED, IT IS TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. WHEN AVAILABLE, A DEVICE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS A TUMOR IN THE THALAMUS. SEVERAL MRIS UP TO 1, 5T HAVE BEEN CARRIED OUT, BUT THESE MRIS DON'T HAVE ENOUGH RESOLUTION. IN ORDER TO CARRY OUT A HIGH ENOUGH RESOLUTION MRI, THE PATIENT HAS TO BE EXPLANTED OF HIS COCHLEAR IMPLANTS - THE PATIENT IS BILATERALLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128374 MED-ED COMBI 40+ COCHLEAR IMPLANT SYSTEM PULSAR STANDARD MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention